Regulatory Operations Specialist II – Clinical & Analytical Sciences
Location: Mumbai, India
Category: Clinical / Regulatory Operations
Job ID: 254980
Work Environment: Office-based
Experience Required: 4–6 Years
Role Overview
We are seeking a highly skilled Regulatory Operations Specialist II to support clinical and analytical development projects within a regulated pharmaceutical environment. This role plays a critical part in providing analytical and dissolution testing support for developmental and comparative dissolution projects, while ensuring full compliance with GxP, ICH, and regulatory standards.
The position requires strong technical expertise, cross-functional collaboration, and hands-on involvement in analytical investigations supporting global drug development programs.
Key Responsibilities
Provide analytical support for developmental and comparative dissolution projects received from global client sites
Act as a key interface with contract laboratories, CROs, suppliers, customers, and internal stakeholders to drive project performance and timelines
Coordinate with CROs to ensure project deliverables are completed within agreed timelines
Design scientific experiments and actively monitor laboratory work
Analyze experimental and dissolution data sets, interpret results, and provide scientific conclusions
Recommend continuation, expansion, or termination of investigations based on data and scientific rationale
Prepare and review test methods, protocols, technical documents, and analytical reports
Ensure accurate documentation, proper recording of raw data, and compliant data retention
Perform troubleshooting related to analytical instruments, dissolution methods, and laboratory processes
Conduct dissolution investigations, including comparative and multimedia dissolution testing
Ensure strict adherence to GMP, safety standards, and regulatory requirements
Support internal and external audits and inspections
Contribute to regulatory document readiness, formatting, publishing, and submission activities
Technical Expertise & Knowledge Areas
In-vitro dissolution testing and dissolution investigations
Comparative dissolution testing, including multimedia dissolution
Oral solid dosage form formulation (basic understanding)
Pharmaceutical product lifecycle management
Regulatory operations, regulatory publishing, and document management systems
GxP, ICH guidelines, and global regulatory compliance
Qualifications
Education
Bachelor’s degree in Pharmacy or a related scientific discipline (required)
Master’s or PhD in a relevant field is an advantage
Equivalent relevant experience may be considered in lieu of formal education
Language Proficiency
English (Speaking): ILR Level 3+ or higher
English (Reading/Writing): ILR Level 4 or higher
Professional Experience
4–6 years of experience in one or more of the following areas:
Regulatory Operations or Regulatory Affairs
Quality Assurance
Analytical Sciences or Formulation Sciences
Drug development and pharmaceutical manufacturing
Experience with regulatory document formatting, publishing readiness, and submission processes
Exposure to clinical or scientific research environments is desirable
Demonstrated ability to manage audits, inspections, and compliance activities
Core Competencies
Strong analytical and problem-solving capabilities
Excellent organizational and time management skills
High attention to detail with a strong quality mindset
Effective interpersonal and stakeholder communication skills
Customer-focused approach with the ability to work across global teams
Technical proficiency with Microsoft Office and document management systems
Preferred Qualifications
Advanced degree with relevant industry experience
Diploma or certification in Regulatory Affairs
Knowledge of pharmaceutical data management systems
Prior experience in regulatory publishing and lifecycle documentation
Why Join This Opportunity
Work on global drug development programs in a regulated environment
Gain exposure to regulatory operations, analytical sciences, and clinical development
Collaborate with cross-functional and international teams
Build a long-term career in pharmaceutical regulatory and clinical operations
Equal Employment Opportunity
The organization is committed to providing equal employment opportunities and fostering a diverse and inclusive workplace. Reasonable accommodations are available throughout the recruitment process.
SEO Keywords Optimized
Regulatory Operations Specialist Jobs, Regulatory Affairs Jobs Mumbai, Pharmaceutical Regulatory Operations India, Analytical Dissolution Specialist Jobs, Clinical Regulatory Careers India, GxP Compliance Jobs, Regulatory Publishing Roles
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